Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled, intervention trial was conducted in a general population of South Africa to test this hypothesis.

Measure the protective effect on the incidence of genital ulcer disease [ Time Frame: M3, M12 and M21 ]

Enrollment:

3274

Study Start Date:

July 2002

Study Completion Date:

July 2005

Detailed Description:

This study is a randomized controlled intervention trial. This multi-centre study will take place in 3 centers located around Johannesburg, in the areas of Orange Farm, Sebokeng and Evaton. The intervention group patients (circumcised at the beginning of the trial) and the control group (uncircumcised men) will be followed during 21 months (from M.0 to M. 21). Randomization and medicalized circumcision will be performed at M.0 in the intervention group and might be optional in the control group at end of study. The medicalized circumcision effectiveness will be evaluated on and after M.3 (3 months after medicalized circumcision). Incidences (of HIV, HSV-2 infections and genital ulcer disease) will be compared from M.3 to M.21 between the intervention group and the control group. An intermediate analysis will take place at M. 12.

Eligibility

Ages Eligible for Study:

18 Years to 24 Years (Adult)

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Uncircumcised men aged 18-24 years

Be in good general condition with normal physical and genital examinations

Consenting to participate in the trial and to sign an informed consent

Consenting to randomization of the medicalized circumcision schedule (performed at the beginning of study for the treated group, optional at the end of study for the control group)

Consenting to avoid sexual contact (except with condom protection) during the 6 weeks following the medicalized circumcision

Consenting to blood tests at M.0, M.3, M.12 and M.21 tested for HIV, HSV-2 and syphilis.

Exclusion Criteria:

Men with AIDS

Men with contraindication for circumcision

Men thinking of moving away from the trial sites within the 21 months following inclusion

Men with clinical sexually transmitted diseases (STDs) (those men could be included after treatment)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122525